(ii)
REPORT OF MEETING
WORLD HEALTH ORGANIZATION /
SECRETARIAT OF THE PACIFIC COMMUNITY
INAUGURAL MEETING OF THE PPHSN PUBLIC HEALTH
LABORATORY NETWORK
(Noumea, New Caledonia, 19-20 April 2000)
Secretariat of the Pacific Community
Noumea, New Caledonia
2001
© Copyright Secretariat of the Pacific Community, 2001
All rights for commercial / for profit reproduction or translation, in any form, reserved. The SPC authorises the partial reproduction or translation of this material for scientific, educational or research purposes, provided that SPC and the source document are properly acknowledged. Permission to reproduce the document and/or translate in whole, in any form, whether for commercial / for profit or non-profit purposes, must be requested in writing. Original SPC artwork may not be altered or separately published without permission.
Original text: English
Secretariat of the Pacific Community Cataloguing-in-publication data
Inaugural meeting ot the PPHSN Public Health Laboratory Network (19-20 April 2000 : Noumea, New Caledonia)
Report of Meeting
1.Public health - Oceania. 2.Medical laboratories - Oceania - Utilization.
1.Title 2.Secretariat of the Pacific Community 3.Series
614.429 / AACR2ISBN 982–203–812–7
Secretariat of the Pacific Community
BP D5
98848 Noumea Cedex
New Caledonia
Telephone: +687 26 20 00
Facsimile: +687 26 38 18
E-mail:
Prepared for publication and printed at the
Secretariat of the Pacific Community Headquarters,
Noumea, New Caledonia, 2001
TABLE OF CONTENTS
Page
- AGENDA1
- OBJECTIVES OF THE MEETING2
- SUMMARY OF THE WORKING GROUPS3
- LIST OF PARTICIPANTS19
ANNEX 1 — WORKING GROUP B2 – INDICATIONS AND 26
PROTOCOLS FOR SPECIMEN COLLECTION, STORAGE, AND
TRANSPORT TO LEVEL 2 AND 3 LABORATORIES. PLAN OF ACTION
ANNEX 2 — LIST OF DOCUMENTS28
ANNEX 3 — GUIDELINE FOR THE WORKING GROUPS29
1
I. AGENDA
Wednesday 19 April 2000
8:00Registration
8:15Opening ceremony
Election of chairpersons and drafting committee
9:00Objective and expected outputs of the meeting
9/15Coffee break
9:30Self-introduction of the participants, with brief presentation of their facilities and activities
10:30Background:- From PPHSN to PPHSN public health laboratory network
- Existing CDs prevention and control strategies in the Pacific Island region
- Summary of the findings from the laboratories assessment
- Legal protection
11:15Working groups:
1.Laboratories lists and contacts
2.Target diseases for level 2 laboratories
12:00Working groups presentations and plenary discussion / recommendations
12:30Lunch break
13:30Working groups:
1.List of tests
List of equipment/reagents /disposable available/needed, and starting stocks and procurement procedures
2.Indications and protocols for specimen collection, storage and transport to level 2 and 3 laboratories
- Roles of level 3 laboratories
Quarantine services & airlines: specimen transport constraints & problems, and proposed solutions. Preparation of the telemeeting on quarantine issues
4. Flow of information and communication, with plan of implementation
15:00Tea break
15:15Group work (continued)
16:30Break — Drafting committee consolidates draft plan of action
Thursday 20 April 2000
8:00EWORS presentation
8:15Working group presentations and plenary discussion / plan of operations
10:15Coffee break
10:30Telemeeting on quarantine issues
11:20Working groups:
- Human resources needs and solutions: staffing & training
- Funding mechanisms and overall coordination
- Quality control program
- Legal protection
13:00Lunch break
13:30Drafting committee consolidates draft plan of action
15:00Working groups presentations only
15:45Tea break
16:00Plenary discussion: plan of action of last group works, overall plan of action. Summary of the meeting (with key issues)
17:00Closing ceremony
II. OBJECTIVES OF THE MEETING
Within the framework of the Pacific Public Health Surveillance Network, development of a plan of operation identifying needs and resources for the implementation of the public health laboratory Network in the Pacific Islands region.
Expected Outputs (with existing/possible constraints for each output)
List of laboratories involved in the PPHSN Public Health Laboratory Network, including the contact person(s) in each laboratory. Plan of action to have all these laboratories involved in the Network
List of target communicable diseases for level 2 laboratories
List of tests to be conducted (level 2 and level 3 laboratories) and specimen to be taken with practical comments on technical issues
List of equipment/reagents/disposable materials available/needed by level of laboratory (specimen collection, storage, shipment, and testing) with starting stocks, procurement procedures
Indications and protocols for specimen collection, storage and transport to level 2 and 3 laboratories
Roles of level 3 laboratories clearly identified
Legal protection:
Quarantine services and airlines and potential or existing transport problems/constraints listed. Plan for involving airlines and quarantine services through briefing + agreement, and solving the problems
Intellectual property problems and proposed solutions listed
Flow of information and communication designed, with plan of implementation
Human resources needs and possible solutions identified: staffing and training
Funding mechanisms (initial & recurrent costs) envisaged
Realistic quality control program
Procedures for overall coordination and implementation of the plan of action
III. SUMMARY OF THE WORKING GROUPS
WORKING GROUP A1
LABORATORIES LISTS AND CONTACTS
(Wednesday 19 April 2000, morning)
1.The first group recommendations is that all endeavours will be made to increase “recruitment” (response) from level 1 laboratories including private facilities if possible. In all cases this will be only if Pacific Island country/territory Governments will agree to such arrangements. The group recommended that e-mail communication means at level 1 laboratories (at least at the national level) will be strengthened and that the necessary support will be sought.
2.The group endorsed the list of the currently proposed level 2 lab network. However a specific recommendations was made for New Zealand to decide and formerly indicate to PPHNS instances which facilities will precisely/namely be involved (e.g., ESR[1], PPTC[2]). Considering that the Malardé Institute is in a transitory phase complementary with New Zealand participation must be considered.
3.A list of criteria to be fulfilled for level 2 laboratories was discussed. Level 2 laboratories must:
have an acceptable[3] turn around of specimen to work on;
be able to cope with an increase of flow of specimen due to an outbreak situation (provided that specimen would have been appropriately selected beforehand);
willingness to participate and enhanced laboratory capability.
4.It was recalled that in the case of Guam some necessary improvement in the technical equipment was found necessary at the time of the on-site expertise carried out by the Pasteur Institute in late 99 specially for the diagnosis for influenza, dengue and measles.
5.Regarding Fiji, laboratory support in training, follow-up and advisory services, in order to enhance technical capacity, was similarly flagged out at the same time.
WORKING GROUP A2
TARGET DISEASES FOR LEVEL 2 LABORATORIES
(Wednesday 19 April, morning)
6.The working group decided that there should be two groups of priority diseases at level 2 laboratory.
First Target Diseases
- Measles (rubella)
- Dengue
Second target diseases
- Influenza
- Leptospirosis
- Cholera
- Typhoid
7.The first group will be under surveillance and diagnostic procedures at level 2 laboratories at the inception of the network. Two issues were identified as per the immediate inclusion of the second group of diseases:
- Funding
- Technical/reagents/equipment
8.During the first 12-18 months of operations of the public health laboratory network activities will be monitored in order to find out solutions to cope with the two above mentioned issues.
9.In the interim the question was raised whether operational guidelines could be developed so that level 1 laboratories would know what to do with suspected cholera and typhoid outbreaks on one hand, and influenza and leptospirosis on the other hand (e.g., locally testing for cholera and typhoid and referring to level 3 laboratories for influenza and leptospirosis). It was decided that further working group discussions will resolve that question.
10.The group also recommends that the identified resource problem will be duly acknowledged in order to facilitate the quest for solutions.
11.The point was also raised that it might not be necessary requirements for all level 2 laboratories that they should be able to implement diagnostics facility for influenza and leptospirosis at the inception of the network.
12.It was also flagged out that diagnostic capacity building of level 2 labs should not happen at the expenses of the possibility of diagnosing/monitoring diseases of local importance.
13.It is to note that Acute Haemorragic Conjunctivitis (AHC) is not considered of being part of the list of diseases that level 2 laboratories will monitor in the near future (as such, AHC outbreaks will continue to possibly be monitored on PACNET, but will no longer be namely on the list of priority diseases targeted by PACNET).
WORKING GROUP B1
LIST OF TESTS FOR LEVEL 2 LABORATORIES
LIST OF EQUIPMENT/REAGENT/DISPOSABLE AVAILABLE/NEEDED
STARTING STOCKS AND PROCUREMENT PROCEDURES
(Wednesday 19 April, afternoon)
Action points
14.The supplies required by level 2 laboratories are dependant on the methodologies to be used and the number of specimens likely to be received.
15.General requirements
- e-mail facilities, (L1, L2 and L3 level labs)
- -80° C facilities including racks boxes/ boxes/serum storage vials
- ELISA facilities
- reagents (minimum stock requirements)
16.List of tests for level 1 and 2 laboratories
Disease / Laboratories level 1 / Laboratories level 2Measles/Rubella / (refer all samples to L2) / IgM ELISA
Typhoid / Routine (refer a sample of strains to L2) / Antibiotic resistance and QC
Vibrio / Routine (refer a sample of specimens to L2) / confirmation (serotyping) and QC
Influenza / (refer all samples to L2) / Immunofluorescence on nose-swabs
ELISA on nose-swabs
Dengue (*) / (refer all samples to L2) / IgM ELISA
HAI (paired serum)
PCR (long term prospect)
Leptospirosis (**) / (refer all samples to L2) / ELISA
MAT
(*) For development of further testing capacity PCR is recommended over viral isolation.
- Setting of adequate premises and protocols for PCR would need to be rigorous
- PCR would give considerable additional capacity such as typing of influenza.
(**) The problem needs to be quantified first (IPNC, lab in Brisbane)
Explanatory note
ELISA = enzyme-linked immunosorbent assay
- HAI = hemagglutination inhibition
- PCR = polymerase chain reaction
- MAT = micro-agglutination test(direct agglutination)
- IgM, IgG = immunoglobulin class M or G
Starting stocks and procurement procedures
Stock
17.Minimum stock needs to be held to enable immediate response/dispatch. The minimum level will depend on potential demand.
Procurement procedures
18.This will depend on who is funding supplies and needs to be looked at further.
19.Recommendations
- Measles/dengue minimum stock: 1 kit
- Establish good communication link by e-mail/fax to enable request of further reagents
- Supply of minimum stocks need to be staggered to avoid problems with expiry dates
- Review of laboratories who develop their own reagents/tests to ensure quality control of in-house reagents/tests.
- That these minimum stocks held are not for clinical services but for the public health surveillance.
- Funding mechanism needs to be discussed.
- Appoint a working group to investigate further.
Working Group
20.To appoint a working group to define what is a suitable number of samples/methodologies per each disease.
21.It is difficult to predict what supplies/stocks are required, a review after a period of time will be needed to readjust the laboratory supplies/minimum stocks.
22.Within the working group there is need of representation from epidemiologists and from L3, L2 and L1 labs.
a)What are appropriate methodologies?
b)What number of samples are appropriate/expected?
c)What is the scope for collection of samples at the field level, how will this impact the L2 methodologies selected?
d)What is the potential for future PCR capacity at L2 ( particularly Guam, Fiji) including consideration of what is required to set adequate premises and rigorous protocols to prevent erroneous results?
23.Aim should be to present a range of choices/options that can be used accordingly to the individual countries needs and expectations.
24.It should be clearly identified what lab does what, and all the labs should be listed with this information in a document.
Laboratory Requirements for Dengue Diagnosis at Level 2 Laboratories – 3 points of view
25.First point of view
a)IgM ELISA is the most feasible testing procedure for laboratories in Fiji and Guam. Despite of non-specific reactions, IgM ELISA could be a useful method, if the proper sampling, interpretation and confirmation (level 3 laboratory) procedures are provided.
b)A collection of paired sera for HAI test should also be promoted at same time. A clear laboratory guideline and quality control mechanism should be established for HAI test.
c)An establishment of PCR for all level 2 laboratories should be planned as a long-term plan, including training.
26.Second point of view
a)The strategy of detection of epidemics at level 2 laboratory must involve conventional serological methods (detection of total IgM using MAC-ELISA, detection of total Ig using HIA). In order to obtain a clear biological confirmation of cases, these methods require the collection of 2 samples 8-10 days apart in order to evidence significant increasing of antibodies.
b)This protocol requires to be based on an efficient network of selected physicians in order to optimise the efficiency of surveillance (syndromic surveillance).
c)The implication of level 3 laboratories (PCR and/or viral isolation) could be activated by level 2 laboratories in a case of acute and expanded epidemic situation in order to obtain as soon as possible the confirmation of the etiology.
27.Third point of view
a)Single IgM ELISA result is not confirmatory but can be useful in the context of a suspected outbreak to enable a vigilant and appropriate public health response.
b)Paired serum collection has been tried (& discussed) in the past and many practical issues have prevented a successful system from being established.
c)To enable PRO-ACTIVE vigilant surveillance use of ELISA IgM on single samples ALONGSIDE encouragement for paired sera should be used. Level 2 labs should have ELISA IgM facilities for dengue & use discretion per its use when paired sera are not available.
d)Insistance of paired sera (e.g. HAI confirmation of dengue) will limit the ability of some areas to obtain samples for referral to level 2 labs for dengue surveillance.
e)Suggest use of IgM ELISA, HAI if paired sera available & referral of IgM positive samples for confirmation at level 3 (PCR testing).
WORKING GROUP B2
INDICATIONS AND PROTOCOLS FOR SPECIMEN COLLECTION, STORAGE, AND TRANSPORT TO LEVEL 2 AND 3 LABORATORIES
(Wednesday 19 April, afternoon)
Plan of action
28.Indications for specimen collection
What?
Guidelines for specimen collection (based on surveillance case definitions) for the 6 target diseases: when and what to collect.
Who?
PPHSN-CB, as part of the development of surveillance and response guidelines
When?
By November 2000
Comments
- Draw on existing guidelines and reference sources.
- Consider external monitoring of the demand for and appropriate use of public health laboratory services (e.g. by EpiNet)
29.Shipping guidelines
What?
Draft detailed guidelines for packing, labelling, and shipping specimens, including an assessment of likely demand.
Who?
A Network member if time available, but more likely by a consultant (x 1 month)
When?
Process underway by November 2000
Comments
- Draw on existing guidelines and reference sources.
- Incorporate communications methods to share information and track shipped specimens.
- Consider formalizing arrangements with selected transit hubs (e.g. Nadi, Brisbane).
- Consider outsourcing shipping arrangements to a private company.
- Incorporate feedback from recipient labs on adequacy of packing.
30.Shipping supplies
What?
Supplies for specimen collection and shipping provided to level 1 labs, and in larger quantities to selected central sites.
Who?
- “Prime” the system with supplies provided by WHO.
- Seek other support for maintenance supplies (e.g. recycling from L3 labs, donor or L3 lab contributions).
When?
Initial supplies provided by August 2000.
Comments
Incorporate an inventory system and an audit of utilisation, developed by PPHSN LabNet Working Group.
31.Shipping arrangements
What?
Convene meetings in Nadi and Guam with airline representatives, shipping agents, and representatives of airport services and customs to consider and resolve shipping requirements and storage in transit.
Who?
PPHSN-CB members convene Nadi meeting; seek support from Micronesia-based PPHSN LabNet members to convene Guam meeting.
When?
September 2000
Comments
- Draw on existing information sources for background on current IATA[4] and non-IATA requirements.
- Seek agreements for support.
32.New technologies
What?
- Explore other options for point of care (field) tests, and for specimen collection, such as filter paper methods, to reduce shipping complexity and cost.
- Assess cost benefit.
Who?
Seek interest and support from L3 reference laboratory staff.
When?
Ongoing.
33.Indicator diseases
What?
Incorporate a more common condition, such as (suspected) influenza, as soon as possible, with guidelines to allow its use as a continuing test of the system.
Who?
PPHSN LabNet
When?
As soon as possible.
34.Training
What?
Develop a training plan for country-level training of L1 staff in packing and shipping specimens.
Who?
Seek support from reference laboratories involved in training.
When?
November 2000
Comments
Such training may be incorporated into regularly scheduled visits for other laboratory training or quality assurance monitoring.
35.Funding
What?
Consider the funding implications as each of the above is developed, and incorporate this into overall PPHSN LabNet funding requirements.
Who?
Those responsible for each of the above.
The action plan of the working groupe B2 is presented in a Table in Annex 1 pages 26 and 27
WORKING GROUP B3
ROLES OF LEVEL 3 LABORATORIES
(Wednesday 19 April, afternoon)
Roles of Level-3 laboratories:
Quality control Virulence studies
PCR: molecular typingStrain identification
36.Consideration needs to be given to communication networks and how the information will be disseminated in a timely relevant manner.
37.Quality control
- Could be achieved by expanding the RCPA & NRL in Australia to forward testing panel (quality control) to Pacific Island Nations – specifically level 2 labs.
- Consideration should also be given to introducing quality management procedures in place similar to NAZA + IS09001.
38.PCR: molecular typing
- Appropriateness of testing and rôle of specific laboratories (level 3) – laboratories guides.
- Minimum of two laboratories.
39.Virulence studies
Needs to be clearly defined and may have minimal impact (depending upon organism in question on Public Health impact).